Announcer: From the
National Institutes of Health in Bethesda, Maryland, this is All About Grants.

Megan Columbus:Welcome to another edition of All About Grants.
I’m your host, Megan Columbus, coming to you from the NIH Office of Extramural
Research.Today, our focus is on All About Sharing, that is, a discussion about NIH sharing policies.
With us today, we have J.P. Kim, who is the Director of the Division of Extramural
Inventions & Technology Resources in the Office of Extramural Research.
Some investigators are puzzled when we mention that the NIH has data sharing
and model organism sharing policies. They just assume they have always been
able to ask any investigator for animal models, reagents, and other unique
research resources. J.P., can you talk
to us about the purpose of NIH sharing policies?

J.P.:Certainly, NIH sharing policies they actually exist to continue to
promote the sharing of research resources that are developed using NIH funds. It includes reagents, cell lines, animal
models, and other research resources. Investigators have always been able to
ask any other investigator for research resources, but even when I was a cancer
researcher, I was aware that not all investigators shared their research
resources as broadly as we had hoped.

Megan:As applicants are developing their applications, is there anything
investigators should consider in addressing the NIH data sharing policy, or the
NIH model organism sharing policy, or other NIH sharing policies?

J.P.: Yes, the best way for an investigator to
develop plans and such, is that when developing their sharing plans,
investigators they should confer with their institution’s sponsored research
office regarding how these expectations should be addressed.The institutional office knows the NIH
policies and rules that they must comply with under NIH funding, as well as
their own institution’s rules and policies.

Megan: So when did NIH sharing policies go
into effect?

J.P.:Well, some people believe the sharing of research resources only began
in 1999 with the adoption of the NIH Research Tools Policy, but you have to
understand that sharing policies have been in the Grants Policy Statement since
before 1976 in one form or another. The NIH has a
mission to improve public health through research, and it actually has a
longstanding legislative mandate to make available to the public the results of
the research activities that it supports and conducts. So sharing policies are
not new and have been in place for many years.

Megan:What exactly do the policies address? What should be shared?

J.P.:NIH sharing policies broadly address unique research resources that are
developed with NIH funding. Different policies provide different examples, but
the basic premise is the same, sharing of research resources funded by the NIH.
For example, research resources can encompass both data and materials. Among
these examples are data, cell lines, monoclonal
antibodies, reagents, animal models, growth factors, combinatorial chemistry and
DNA libraries, clones and cloning tools, methods, laboratory equipment and machines,
as well as databases, software, materials subject to copyright.

Megan:Does this include resources for which a patent application has been
submitted?

J.P.:Actually yes, the filing of a patent application does not exclude a
research resource from being shared and being subject to NIH sharing policies.

J.P.:Well the NIH data sharing policy came out in 2003 and is a policy that
expects a sharing plan that needs to be submitted for applications requesting
$500,000 or more in direct costs in any given year, or state why data sharing
isn’t possible. This does not mean that investigators should not be sharing in
other grant applications that don’t get to that threshold 500,000 amount.

Megan:What types of data should be shared?

J.P.:Some examples include recorded factual data, especially unique data such
as data collected from large surveys, from unique populations, under unique
circumstances, and in the study of rare diseases. Of course, data from human
subjects must obey privacy rules and the applicable informed consent forms.

Megan: So can you tell me a little bit now
about the NIH model organism sharing policy?

J.P.:The model organism sharing policy, like the 2003 data sharing policy,
expects a sharing plan in any grant application which will develop a model
organism. But unlike the data sharing policy, there is no threshold budget
amount.

Megan:What types of model organisms
does the policy apply to?

J.P.: The policy applies to non-human model
organisms and related resources, and some examples include mammalian models,
such as mice and rats, and non-mammalian models such as yeast, fruit flies,
zebra fish, and worms. Specifically excluded from the policy are human specimens
or human cells.

Megan: What do you mean by “related
resources”?

J.P.:Well, in addition to knock-out and transgenic animals, “related
resources” would include, for example, genetic and phenotypic data, viral vectors,
monoclonal antibodies, computer software and databases, stem cells, and any
other resources that would aid in understanding biological systems.

Megan: So does the policy also apply then to
the development of viruses, bacteria, and other organisms?

Megan:Okay, so now that you’ve given an explanation of data sharing policies
and model organism sharing policies, can you talk to me more generally about what
is the best way to comply with NIH sharing policies overall?

J.P.:The most efficient and effective way to share research resources, whether
it be data, model organisms or others, is to put them in a repository that is
designed for distributing that type of resource.NIH-funded repositories are likely the best option
for researchers because, as NIH-funded repositories, those repositories’
operations need to comply with NIH sharing policies as a term and condition of
their grant.

Megan: Thank you for joining us today, J.P.
For NIH and OER this is Megan Columbus.

Announcer: For more information on NIH data
sharing policies, visit sharing.nih.gov or contact us at sharing@nih.gov.